SOP on SOPs (SOP on Standard Operating Procedures) – PST06103 Pharmaceutical Production
NTA Level 6 • Semester 1 • PST06103 SOP on SOPs (SOP on Standard Operating Procedures) Pharmaceutical Production • Source Session/Topic 5 Full source-text version: all educational wording from the extracted learning source is retained; only presenter/tutor metadata and web-layout noise are removed, while formatting is improved for readability. Session 5: SOP on SOPs (SOP on Standard Operating Procedures) Total Session Time: 120 minutes Pre-requisites • None Learning Tasks By the end of this session students are expected to be able to: • Define SOP of SOPs • Explain the components of SOP of SOPs • Develop an SOP of SOPs Resources Needed: • Flip charts, marker pens, and masking tape • Black/white board and chalk/whiteboard markers • LCD projector and computer • Handout 5.1: Format for SOP of SOPs SESSION OVERVIEW |Step |Time |Activity/ |Content | | | |Method | | |1 |05 minutes |Presentation |Introduction, Learning Tasks | |2 |05 minutes |Presentation |Definition | |3 |10 minutes |Presentation |Components of SOP of SOPs | |4 | |Small group |Development of SOP of SOPs | | |90 Minutes |activity | | | | |Presentation | | |5 |05 minutes |Presentation |Key Points | |6 |05 minutes |Presentation |Evaluation | SESSION CONTENTS STEP 1: Presentation of Session Title and Learning Tasks (5 minutes) READ or ASK students to read the learning tasks and clarify ASK students if they have any questions before continuing STEP 2: SOP of SOPs (5 minutes) • In order to write Standard Operating Procedure, another Standard Operating Procedure is needed to standardize and guide the process • The SOP that guides how other SOPs in the organization should be prepared is known as an SOP of SOPs or a mother SOP STEP 3: Components of SOP of SOPs (10 minutes) • Components of the SOP of SOPs; o Purpose ▪ The purpose of SOP of SOPs is to describe procedures for preparation, review and approval of standard operating procedures in pharmaceutical production o Scope ▪ This part of the SOP of SOPs describes the way the SOP of SOPs applies to all SOPs o Responsibility ▪ This part identifies people (Executive/QA officers or other designated persons) responsible for preparation, revision, periodical review and approval of the SOP of SOPs ▪ Persons responsible for the preparation, revision and periodic review of the SOP of SOPS ▪ Person(s) responsible for review and training of the SOP of SOPs ▪ Person(s) responsible for approval of the mother SOP o Procedure ▪ This part should, ▪ Specify the format of all SOPs in the organization ▪ Specify paging and placement of company logo on SOPs ▪ Specify header, content and footer of the SOPs ▪ Specify font style, font size and line spacing in all SOPs ▪ Specify numbering system (and description of characters used in the numbering system) for the SOPs ▪ Specify placement of dates (supersedes, approval date, effective date and review date) for SOPs ▪ Specify the signatories of various SOPs in the organization (i.e. prepared by, reviewed by, approved by) ▪ Specify the content of SOPs ▪ Purpose, scope, responsibility, procedure, revision, abbreviations, annexures, header, footer, as described in session 7) o Revision ▪ Describes revision of SOPs ▪ Provides a revision log showing revision number, effective date and reason for the revision of each SOP revised o Abbreviations ▪ Should show abbreviations or acronyms used in the mother SOP and their expanded form o Annexure ▪ Provides a list of all the annexure used in the mother SOP (e.g. SOPs format, list of codes) STEP 5: Developing an SOP of SOPs (90 minutes) [pic][pic] Refer students to Handout 5.1: Format for SOP of SOPs |Activity: Small Group Assignment (60 minutes) | | | |DIVIDE students in manageable groups | | | |ASK the students to work on the following assignment | | | |Prepare an SOP of SOPs for a Compounding Laboratory in your school | | | |ALLOCATE time for students to do the assignment and presentation | | | |REFER students to recommended references | STEP 6: Key Points (5 minutes) • SOP on SOPs is the standard operating procedure for preparation of all SOPs in an organization • It guides the process of preparing SOPs in all departments of an organization • SOP of SOPs is also known as the mother SOP STEP 7: Evaluation (5 minutes) • What is an SOP? • What is SOP of SOPs? • Mention the components of an SOP of SOPs • Who is responsible for preparing the SOP of SOPs in a pharmaceutical manufacturing company? References Escope, Adriene, (1997). Nimble documentation, the practical guide for World class organization, Milwaukee, Wisconsin, American Society for Quality, Quality Press Garner, Willa Y and Mureen S. Barge, Editors, “Good Laboratory Practices. An agrochemical perspective” ACS Symposium Series 369, American Chemical Society Schmidt, O. (ed) (2000) Pharmaceutical Quality systems, Interpharm Press, Colorado. Shayne C et al (2008), Pharmaceutical Manufacturing Handbook: Production and processes, John Wiley & Sons |[pic] |Handout 5.1: General Format for SOP of SOPs | | SOP ON STANDARD OPERATING PROCEDURES | |Title: |Copy no.: | |Organization/Company: |Page no.: | |SOP of SOPs No.: |Supersedes: | | |Effective date: | |Review Date: |Prepared By |Reviewed By |Approved By | |Designation | | | | |Signature and Date | | | | 8. Purpose 9. Scope 10. Responsibility 11. Procedure 12. Revision 13. Abbreviations 14. 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